Cleared Abbreviated

K020218 - SNAP EEG MONITOR

K020218 is an FDA 510(k) clearance for SNAP EEG MONITOR, manufactured by Nicolet Biomedical, Inc.. The device is a Class 2 Neurology device with product code OLW cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K020218 · Nicolet Biomedical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
90d
Days
Class 2
Risk

K020218 is an FDA 510(k) clearance for the SNAP EEG MONITOR. Classified as Index-generating Electroencephalograph Software (product code OLW), Class II - Special Controls.

Submitted by Nicolet Biomedical, Inc. (Stoughton, US). The FDA issued a Cleared decision on April 22, 2002 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Nicolet Biomedical, Inc. devices

FDA 510(k) Submission Details - K020218

510(k) Number K020218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2002
Decision Date April 22, 2002
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

OLW Device Classification - Class 2, Special Controls

Product Code OLW Index-generating Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electrical Activity Of The Brain By Transformation Of Electroencephalograph Signals Into A Dimensionless Index Number For Use And Interpretation By A Qualified User.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - OLW Index-generating Electroencephalograph Software

All 14
Devices cleared under the same product code (OLW) and FDA review panel - the closest regulatory comparables to K020218.
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K023459 · Datex-Ohmeda · Jan 2003
DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES
K013389 · Datex-Ohmeda · Jan 2002
BIS/EEG MODULE
K012466 · General Electric Medical Systems Information Techn · Oct 2001
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K973596 · Spacelabs Medical, Inc. · Feb 1998